The disposable Air-Q self-inflating laryngeal intubation mask (Air-Q, Mercury Medical, Clearwater, FL, USA) is an extra-glottic airway device which enables blind intubation with a tracheal tube. This intubating laryngeal airway device (ILA) is already commercially available and worldwide certificated (CE 0482), but data about the success rates of blind intubation via this device in adult patients are lacking. Success rates of blind intubations with the non-self-inflating device range between 57 and 97%. Although the self-inflating disposable Air-Q device is certified for blind intubation, the success rate and rate of adverse events associated with this procedure have not been published so far. In a study comparing adverse events of conventional intubation with blind intubation via a different supra-glottic airway device (ILMA) the rates of sore throat and cough were comparable in both groups and were reported in 10-17% of the patients. In a pilot study using the non-self-inflating Air-Q for blind intubation in 19 patients, 10% reported dysphagia and one patient had a bilateral lingual nerve injury which was self-limited. One study using the self-pressurised disposable Air-Q for ventilation of children showed broncho- or laryngospasm in 3% and mucosal damage such as blood stained ILA or sore throat were reported in 1%. This data suggests that the rate of adverse events using the Air-Q supra-glottic device are comparable to other devices such as LMA. * Trial with medical device
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
Patients will be intubated using the Air-Q Laryngeal Mask.
Medical University Lodz
Lodz, Poland
University Hospital Zurich, Institute of Anaesthesiology
Zurich, Canton of Zurich, Switzerland
KantonsSpital Winterthur
Winterthur, Switzerland
Success rate of blind intubation via the disposable Air-Q self-inflating laryngeal intubation mask.
Success is defined as placement of a tracheal tube into trachea with no more than two insertion attempts.
Time frame: 300 seconds
Time for insertion of the Air-Q laryngeal mask
defined as time beginning at the moment the ILA enters the mouth until the appearance of the capnography waveform
Time frame: 300 seconds
Time for insertion of the tube
defined as the time beginning at the moment of insertion of the tube through the laryngeal mask until the appearance of the capnography waveform
Time frame: 300 seconds
First attempt rate and second attempt rate
Time frame: 300 seconds
Time for removal of the Air-Q ILA device after successful intubation
Time frame: 500 seconds
Rate of misplacement of the ILA
Time frame: 300 seconds
Rate of misplacement of the tube
Time frame: 500 seconds
risk factors of insertion failures
Time frame: 500 seconds
Rate of airway injuries
Time frame: 5 hours
Tightness during leak test before relaxation
Time frame: 300 seconds
Tightness during leak test after relaxation
Time frame: 300 seconds
Maximum drop of saturation during airway management
Time frame: 500 seconds
Rate of adverse events
including, but not limited to suspicion of aspiration or regurgitation (gastric fluid in the ventilation tube or hypopharynx), bronchospasm, airway obstruction, coughing, dental-, tongue-, lip- pharyngeal or laryngeal trauma
Time frame: 5 hours
Rate of necessity of alternative airway device
Time frame: 500 seconds
Rate of blood stained devices after removal of the ILA
Time frame: 500 seconds
Postoperative coughing after 2 hours and the next morning
Time frame: 24 hours
Postoperative hoarseness after 2 hours and the next morning
Time frame: 24 hours
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